Method for predicting insulinopenic type 2 diabetes

Abstract

The present invention relates to an in vitro method, for predicting a risk of onset of type 2 diabetes in a subject, which method comprises the steps of: a) measuring the concentration of bacterial 16S rDNA in a biological sample of said subject; and b) comparing said measured concentration of bacterial 16S rDNA to a threshold level; wherein a measured concentration of bacterial 16S rDNA higher than the threshold level is indicative of an increased risk of onset of type 2 diabetes in the subject, and a measured concentration of bacterial 16S rDNA lower than the threshold level is indicative of a decreased risk of onset of type 2 diabetes in the subject.

1 . An in vitro method for predicting a risk of onset of type 2 diabetes in a subject, which method comprises the steps of:
 a) measuring the concentration of bacterial 16S rDNA in a biological sample of said subject; and   b) comparing said measured concentration of bacterial 16S rDNA to a threshold level;   
       wherein a measured concentration of bacterial 16S rDNA higher than the threshold level is indicative of an increased risk of onset of type 2 diabetes in the subject, and a measured concentration of bacterial 16S rDNA lower than the threshold level is indicative of a decreased risk of onset of type 2 diabetes in the subject. 
     
     
         2 . The in vitro method according to  claim 1 , wherein a measured concentration of bacterial 16S rDNA in the biological sample of the subject which is lower than the threshold level is indicative of a decreased risk of onset of type 2 diabetes with predominant insulinopenia. 
     
     
         3 . The in vitro method according to  claim 1 , wherein a measured concentration of bacterial 16S rDNA higher than the threshold level is further predictive of pancreatic beta cell failure. 
     
     
         4 . The in vitro method according to  claim 1 , wherein a measured concentration of bacterial 16S rDNA in the biological sample of the subject which is lower than the threshold level is indicative of a decreased risk of onset of type 2 diabetes with predominant insulinopenia within 9 years from the sampling. 
     
     
         5 . The in vitro method according to  claim 4 , wherein a measured concentration of bacterial 16S rDNA in the biological sample of the subject which is lower than the threshold level is indicative of a decreased risk of onset of type 2 diabetes with predominant insulinopenia within a period of 6 to 9 years from the sampling. 
     
     
         6 . An in vitro method for predicting a risk of hepatic cytolysis in a subject, which method comprises the steps of:
 a) measuring the concentration of bacterial 16S rDNA in a biological sample of said subject; and   b) comparing said measured concentration of bacterial 16S rDNA to a threshold level;   
       wherein a measured concentration of bacterial 16S rDNA higher than the threshold level is indicative of an increased risk of hepatic cytolysis. 
     
     
         7 . The in vitro method according to  claim 1 , wherein the threshold level is 0.15 ng/μL of bacterial 16S rDNA. 
     
     
         8 . The in vitro method according to  claim 1 , wherein the biological sample is selected from the group consisting of blood, serum and plasma sample. 
     
     
         9 . The in vitro method according to  claim 1 , wherein the concentration of bacterial 16S rDNA is measured by real-time PCR. 
     
     
         10 . The in vitro method according to  claim 1 , wherein the subject is at risk of diabetes. 
     
     
         11 . The in vitro method according to  claim 10 , wherein the subject displays at least one diabetes risk factor selected from the group consisting of:
 a waist circumference of more than 102 cm in men or of more than 88 cm in women;   smoking;   a fasting glycemia equal or superior to 6.1 mmol/L;   hypertension; and   family history of diabetes.   
     
     
         12 . The in vitro method according to  claim 1 , wherein the subject is free of central adiposity, free of a fasting glycemia equal or superior to 6.1 mmol/L or free of the metabolic syndrome. 
     
     
         13 . The in vitro method according to  claim 1 , wherein the subject is 30-65 years old. 
     
     
         14 . The in vitro method according to  claim 1 , wherein the subject displays a plasma baseline C reactive protein concentration lower than 30 mg/l. 
     
     
         15 . An in vitro method of determining whether a subject suffering from type 2 diabetes is likely to benefit from a treatment regimen that includes a pancreatic beta cell protecting treatment comprising the steps of:
 a) measuring the concentration of bacterial 16S rDNA in a biological sample of said subject; and   b) comparing said measured concentration of bacterial 16S rDNA to a threshold level;   
       wherein a measured concentration of bacterial 16S rDNA lower than the threshold level indicates that the subject is not likely to benefit from a treatment regimen that includes a pancreatic beta cell protecting treatment. 
     
     
         16 . The in vitro method according to  claim 6 , wherein the biological sample is selected from the group consisting in blood, serum and plasma sample. 
     
     
         17 . The in vitro method according to  claim 6 , wherein the concentration of bacterial 16S rDNA is measured by real-time PCR. 
     
     
         18 . The in vitro method according to  claim 6 , wherein the subject is at risk of diabetes. 
     
     
         19 . The in vitro method according to  claim 6 , wherein the subject is 30-65 years old. 
     
     
         20 . The in vitro method according to  claim 6  wherein the subject displays a plasma baseline C reactive protein concentration lower than 30 mg/l.